Device for preparing an implanted medical apparatus for extraction

ABSTRACT

A device for preparing an elongated implanted medical apparatus, such as a cardiac lead, for extraction from the body of a patient. The device includes a first handle and a second handle. At least the first handle has a surface for receiving the implanted apparatus therealong. A wire member having a first end and a second end is positioned to span a distance between the surface of the first handle, and the second handle. The wire member first end is removably engaged with the first handle, and the wire member second end is removably engaged with the second handle. The wire member is sized and arranged to enable the wire member to be wound around a length of the implanted apparatus to facilitate extraction of the apparatus with a lead extraction device.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Non-Provisional applicationSer. No. 13/716,975, filed Dec. 17, 2012, and titled “Device forPreparing an Implanted Medical Apparatus for Extraction”, the contentsof which are incorporated herein by reference.

BACKGROUND

1. Technical Field

This invention relates to a device for facilitating the extraction of animplanted medical apparatus from the body of a patient. Moreparticularly, the invention relates to a device for preparing animplanted elongated medical apparatus for extraction from a bodypassageway by exerting a compressive force along the proximal end of theelongated apparatus to hold the elements of the apparatus in placeduring the extraction procedure.

2. Background Information

A variety of medical treatments and surgical methods entail implanting adevice, such as a pacemaker, in the body of a patient. A pacemaker istypically positioned in a subcutaneous tissue pocket in the chest wallof a patient. A pacemaker lead is implanted in the body of the patientto extend from the pacemaker through a vein into a chamber of thepatient's heart. The lead comprises an elongated apparatus that includesone or more longitudinal cables, wires, coils, etc. (hereaftercollectively referred to as “cables”) encased within an elongatedinsulating body along the length of the lead. Some cables may conductelectrical signals (such as stimulating and/or sensing signals) betweenthe pacemaker and the heart. Other cables may provide strength and/orsupport to the lead. The cables may extend the entire length of thelead, or a segment of that length. The elongated insulating body,generally formed of silicone or a polymer such as polyurethane, servesto simultaneously protect the cables from body fluids, and insulate thecables from one another.

A defibrillator is another example of a cardiac device that utilizesimplanted elongated leads to transmit electrical signals from thedefibrillator to the heart. Leads for defibrillators are generallysimilar to pacemaker leads, and may be affixed either internally orexternally of the heart. As used herein, a “cardiac lead” may refer toeither a pacemaker lead or a defibrillator lead.

While an implanted apparatus, such as a cardiac lead, may have a usefullife of many years, at some point consideration may be given toextracting the lead. However, over time such leads may have becomeencapsulated by fibrotic tissue against the heart itself or the wall ofthe vein, or against other surrounding tissue. Encapsulation isespecially encountered in areas where the velocity of the flow of bloodis low. The fibrotic tissue can be very tough, which makes it difficultto remove the lead from the area of the heart without causing trauma tothe area. When small diameter veins through which a cardiac lead passesbecome occluded with fibrotic tissue, separation of the lead from thevein can cause severe damage to the vein, including the possibledissection or perforation of the vein. In such cases, separation of thelead from the vein is usually not possible without restricting orcontaining movement of the lead, i.e., fixing the lead in position withrespect to the patient, in particular, with respect to the patient'svein.

To avoid this and other possible complications, some useless cardiacleads are simply left in the patient when the pacemaker or defibrillatoris removed or replaced. However, this practice can incur the risk of anundetected lead thrombosis, which can result in stroke, heart attack, orpulmonary embolism. The practice can also impair heart function, sinceplural leads can restrict the heart valves through which they pass.Other potential risks include obstruction of fluid flow through the veinby the inoperable lead, and migration of the lead such that it mayinterfere with the pacing or defibrillating function. Finally, thepresence of an inoperable lead may also contribute to undesirableconditions such as septicemia or endocarditis.

Surgical removal of a cardiac lead in such circumstances often involvesopen heart surgery. However, open heart surgery is accompanied bysignificant risk and cost to the patient, as well as a potential forunintended complications. A variety of methods and apparatuses have beendevised for use as alternatives to open heart surgery for cardiac leadremoval. Several of these methods and apparatuses are described inrelated patent documents, such as U.S. Pat. No. 5,697,936, titled“Device for Removing an Elongated Structure Implanted in BiologicalTissue”; U.S. Pat. No. 5,507,751, titled “Locally Flexible DilatorSheath”; U.S. Pat. No. 5,632,749, titled “Apparatus for Removing anElongated Structure Implanted in Biological Tissue”; U.S. Pat. No.5,207,683, titled “Apparatus for Removing an Elongated StructureImplanted in Biological Tissue”; U.S. Pat. No. 4,943,289, titled“Apparatus for Removing an Elongated Structure Implanted in BiologicalTissue”; U.S. Pat. No. 5,011,482, titled “Apparatus for Removing anElongated Structure Implanted in Biological Tissue”; U.S. Pat. No.5,013,310, titled “Method and Apparatus for Removing an ImplantedPacemaker Lead”; U.S. Pat. No. 4,988,347, titled “Method and Apparatusfor Separating a Coiled Structure from Biological Tissue”; U.S. Pat. No.5,423,806, titled “Laser Extractor for an Implanted Object”; U.S. Pat.No. 6,136,005, titled “Apparatus for Removing a Coiled StructureImplanted in Biological Tissue, Having Expandable Means including aLaterally Deflectable Member”; U.S. Pat. No. 6,419,974, titled “RadioFrequency Dilator Sheath”, U.S. Pat. No. 6,687,548, titled “Apparatusfor Removing an Elongated Structure Implanted in Biological Tissue”;U.S. Pat. No. 6,712,826, titled “Apparatus for Removing an ElongatedStructure Implanted in Biological Tissue”; U.S. Pat. No. 7,359,756,titled “Apparatus for removing an Elongated Structure implanted inBiological Tissue”; U.S. Pat. No. 7,651,504, titled “Device for Removingan Elongated Structure Implanted in Biological Tissue”; U.S. Pat. No.8,192,430, titled “Device for Extracting an Elongated StructureImplanted in Biological Tissue; U.S. Pat. Publ. No. 2005/0192591, titled“Device for removing an Elongated Structure Implanted in BiologicalTissue”; U.S. Pat. Publ. No. 2006/0235431, titled “Lead ExtractionDevice”; U.S. Pat. Publ. No. 2010/0222787, titled “Tension ControlDevice”; and U.S. Pat. Publ. No. 2011/0238078, titled “Device and Methodfor Positioning an Implanted Structure to Facilitate Removal”, amongothers. Each of the aforementioned patents and publications isincorporated by reference as if fully set forth herein.

Although the prior art devices have been found to be reasonablyeffective in many situations, physicians continue to encounterproblematic situations in which existing extraction devices may notperform as efficiently as desired for lead removal, and/or in which thecapability of the device to remove the lead could be enhanced bypreparing the lead for removal prior to entry of the extraction deviceinto the body passageway.

One such instance involves the removal of an implanted apparatus, suchas a cardiac lead as described above having one or more cables, etc.,extending along a length of the apparatus. After such apparatuses havebeen implanted for a period of time, the cables can work their waythrough the insulating material, such that they extend outwardly, orlaterally, of the main body of the implanted apparatus along thislength. This arrangement may hamper the ability of the physician toadvance an extraction device over the proximal end of the implantedapparatus, as the laterally extending cable may be positioned in amanner such that it is not easily captured within the extraction deviceas that device tracks along the outer surface of the apparatus.

It would be desirable to provide a device that is capable of arrangingthe proximal end of the implanted apparatus in a manner to facilitateadvancement of an extraction device thereover, and to facilitateextraction of the implanted apparatus from encapsulating tissue in thebody passageway.

BRIEF SUMMARY

The problems of the prior art are addressed by the features of thepresent invention. In one form thereof, the invention comprises a devicefor preparing an implanted medical apparatus for extraction from thebody of a patient. The device includes a first handle and a secondhandle, wherein the first handle has a surface for receiving theimplanted medical apparatus therealong. A wire member having a first endand a second end is positioned to span a distance between the surface ofthe first handle, and the second handle. The wire member first end isremovably engaged with the first handle, and the wire member second endis removably engaged with the second handle. The wire member is sizedand arranged to enable the wire member to be wound around a length ofthe implanted medical apparatus.

In another form thereof, the invention comprises an assembly for removalof an implanted cardiac lead from a body passageway of a patient. Theassembly includes a first handle and a second handle. Each of thehandles comprises a handle body having a ledge surface configured forreceiving a length of the cardiac lead therealong. Each of the handlebodies has a channel extending inwardly from the ledge into an interiorof the handle body, and has an aperture communicating with the channel.Each handle further comprises a tab having a first end and a second end.The tab first end is engaged with the handle body, and the tab secondend has a pin member engaged therewith. The pin member is removablyreceivable in the channel via the aperture. A wire member has a firstend and a second end. The wire member first end is received in thechannel of the first handle through an opening in the ledge surface, andis configured and arranged to be maintained in the channel when the pinmember is received therein. The wire member second end is received inthe channel of the second handle through an opening in the ledgesurface, and is configured and arranged to be maintained in the channelwhen the pin member is received therein. The wire member is dimensionedto span a distance between the respective ledge surfaces.

In yet another form thereof, the invention comprises a method forpreparing an elongated implanted medical apparatus for extraction fromthe body of a patient. A device for preparing the elongated implantedapparatus for extraction is positioned for engagement with a free end ofthe elongated implanted medical apparatus. The device comprises a firsthandle, a second handle, and a wire member spanning a distance betweenthe handles. The wire member has a first end removably engaged with thefirst handle, and a second end removably engaged with the second handle.The elongated implanted apparatus is aligned along a surface of thefirst handle. The second handle is wound around a length of theelongated implanted apparatus in a proximal direction from the firsthandle, such that the wire is wrapped around said length. The first andsecond handles are then removed from the wire wrapped around the lengthof the elongated implanted apparatus.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of one example of a device for preparing animplanted medical apparatus for extraction;

FIG. 2 is an exploded view of the device of FIG. 1;

FIG. 3 illustrates a cardiac lead received along a surface of thedevice;

FIG. 3A illustrates the hands of an operator positioning the cardiaclead along the device shown in FIG. 3;

FIGS. 4 and 5 illustrate successive stages of winding the device aroundthe cardiac lead;

FIG. 6 illustrates the release of the device handles from the lead;

FIG. 7 illustrates the handles as released from the device, and thecompression of the ends of the wire around the lead;

FIG. 8 is a view of a proximal end portion of an implanted cardiac leadintended for extraction from a body vessel, and illustrating a cableprotruding through the outer insulating portion of the lead;

FIG. 9 illustrates the lead and cable of FIG. 8, and further illustratesa wire wound around the lead and cable;

FIG. 10 illustrates the lead, cable, and wire of FIG. 9, and furtherillustrates an end of a lead extraction device arranged for passage overthe proximal end of the lead segment of FIG. 9;

FIG. 11 illustrates the lead, cable, and wire as in FIG. 9, wherein thewire is also wound around a locking stylet;

FIG. 12 is an exploded view of the device as shown in FIG. 2, includinga tether engaged with the wire; and

FIG. 13 illustrates a cardiac lead received along a surface of thedevice as shown in FIG. 3, illustrating the tether engaged with thewire.

DETAILED DESCRIPTION OF THE DRAWINGS AND THE PRESENTLY PREFERREDEMBODIMENTS

For the purposes of promoting an understanding of the principles of theinvention, reference will now be made to the embodiments illustrated inthe drawings, and specific language will be used to describe the same.It should nevertheless be understood that no limitation of the scope ofthe invention is thereby intended, such alterations and furthermodifications in the illustrated device, and such further applicationsof the principles of the invention as illustrated therein beingcontemplated as would normally occur to one skilled in the art to whichthe invention relates. It is understood that like-referenced numeralsare used throughout the figures to designate similar components.

Throughout the specification, when referring to a medical device, or aportion of a device, the terms “distal” and “distally” denote aposition, direction, or orientation that is generally toward, or in thedirection of, the patient when the device is in use. The terms“proximal” and “proximally” denote a position, direction, or orientationthat is generally away from the patient, or in the direction of theoperator, during use of the device.

FIG. 1 illustrates a side view of one example of a device 10 forpreparing an implanted medical apparatus for extraction. FIG. 2 is anexploded view of the device of FIG. 1.

As illustrated, device 10 includes a pair of handles 12, 22. Each handleincludes a handle body 14, 24 having a surface, such as ledge 15, 25,configured for receiving a length of the implanted apparatus along thesurface. A tab 16, 26 extends from handle body 14, 24, preferably at anopposite end of the handle body from ledge 15, 25. Tab 16, 26 includesan aperture 17, 27 for receiving pin 18, 28. Alternatively, the pin maybe integral with the tab. Upon assembly of device 10, an extension 19,29 of pin 18, 28 is received in a suitably-sized opening 13, 23 in thehandle body, as further described herein.

Each main body 14, 24 includes a channel 20, 30 inwardly directed from aslot 21, 31 along ledge 15, 25. Channel 20, 30 extends rearwardly alongmain body 14, 24 from slot 21, 31 to a distance beyond handle bodyopening 13, 23. Although only slot 21 is visible in the orientation ofFIG. 2, slot 31 and the rearward extension of channels 20, 30 may bevisualized by the phantom lines in FIG. 2.

Handles 12, 22 are joined by a generally flexible joinder member, suchas wire 40. In the illustrated example, wire 40 has the generalconfiguration of a rubber band, or a rectangle having rounded ends 42,44. In the example shown, each one of ends 42, 44 is received through arespective one of slots 21, 31, and extends into a respective channel20, 30.

During assembly of device 10, each pin 18, 28 is aligned with arespective tab aperture 17, 27, such that pin extension 19, 29 extendsthrough the aperture. Each tab 16, 26 is pivoted such that pin extension19, 29 is received in an appropriate one of openings 13, 23 as describedabove, and thereby maintains the position of wire ends 42, 44 in therespective channel 20, 30. The assembled device is shown in FIG. 1.

Those skilled in the art will appreciate that handles may be formed(e.g., by molding) from a variety of compositions, such as rigidplastics, and thermoplastic rubbers such as SANTOPRENE®. The tabs andpins may be formed from a more flexible composition, such as anacrylonitrile butadiene styrene (ABS) that is bondable to SANTOPRENE®.The wire may be formed from various compositions, such as metals andmetal alloys, having the strength and flexibility to enable the wire tobe wound around the implanted structure targeted for extraction, and tomaintain its wound configuration following removal of the handles. Oneparticularly preferred example is a stainless steel composition that hasbeen annealed to remove the spring tension from the wire.

Wire 40 will preferably be dimensioned such that respective ledges 15,25 are about 1 to 3 inches (2.54 to 7.62 cm) apart in the assembleddevice shown in FIG. 1, and more preferably, about 2 inches (5.08 cm)apart. Those skilled in the art will appreciate that a wire of greater,or of lesser, dimensions may be used in a particular case, but it isbelieved that a wire having the dimensions recited herein will sufficefor most applications.

Use of device 10 to prepare an implanted medical apparatus forextraction from the body of a patient may be further understood upon adiscussion of FIGS. 3-7. Initially, a proximal end 102 of the implantedlead 100 is severed from the pacemaker, defibrillator, etc., in a mannersuch that it is accessible to the operator. If the lead is of a typehaving a lumen extending therethrough, a locking stylet 120 may beinserted into the lumen of the lead. Locking stylets are well knowndevices for use during the extraction of cardiac leads of the typehaving a lumen therethrough, and are further described, e.g., in theincorporated-by-reference U.S. Pat. Nos. 4,943,289 and 5,207,683.

In this example, device 10 is arranged such that the cardiac leadintended for removal is positioned along the ledge of one of thehandles. As shown in FIG. 3, lead 100 is positioned along ledge 15 ofhandle 12. As further shown in FIG. 3A, the operator may hold lead 100against the ledge with a forefinger F1 and maintain control of thehandle with the thumb T1 of the same hand. The operator then graspshandle 22 between the forefinger F2 and thumb T2 of the other hand.

While continuing to hold lead 100 in place on ledge 15, wire 40 is woundaround lead L in the proximal direction by winding handle 22 around thelead, as shown in FIG. 4. While winding wire 40 around lead 100, each oftabs 16, 26 will typically be pointing in the general direction of thelead. The operator continues to wind handle 22 around lead 100 untilwire 40 is completely wrapped around the lead, as shown in FIG. 5. Atthis time, both handles 12, 22 can be further wound in opposingdirections around lead 100, as indicated by the arrows in FIG. 5, totightly compress wire 40 around the lead.

Once wire 40 has been fully compressed around the lead, tabs 16, 26 arepivoted such that each pin 18, 28 is removed from a respective handlebody opening 13, 23. This action frees wire ends 42, 44 from therespective channel 20, 30, as shown in FIG. 6. Handles 12, 22 may thenbe removed, and wire ends 42, 44 may be squeezed or otherwise compressedaround the lead 100. The lack of spring tension in the annealed wireenables the respective axial ends of the wire to remain compressedagainst the lead as shown in FIG. 7. As shown in FIG. 7, the proximalend of lead 100 has now been prepared for extraction, e.g., by passagethereover of a conventional lead extraction device, such as the devicedisclosed in the incorporated-by-reference U.S. Pat. Publ. No.2006/0235431.

Those skilled in the art recognize that many elongated implanted medicalapparatuses, such as a cardiac (e.g. pacemaker or defibrillator) lead,intended for removal include one or more cables, wires, coils, and thelike (“cables”) that extend along the length of the implanted lead, or aportion of that length. As stated above, conventional lead removaldevices are typically introduced over a proximal end of the lead thathas previously been cut from the cardiac device. However, in some casesone or more of the cables may have worked their way through theinsulation or other outer surface of the implanted lead. Many factorscan cause a cable to work its way through the outer surface of a cardiaclead, such as the body environment in which the lead is positioned, thelength of time in which the lead has been implanted, the degree ofcurvature of the vessel in which the lead has resided, etc.

It may be difficult, if not impossible, to properly advance the tip ofthe extraction or removal device over such a lead, so that theextraction device simultaneously advances over both the lead and anylaterally-extending cable(s). Even when such positioning is possible, itmay require additional unintended effort by the physician and/or othermedical personnel, and may require additional surgical time and expenseto accomplish the extraction.

In order to avoid these disadvantages, it is beneficial to manage,arrange, or otherwise position the proximal end of the implanted leadsuch that cables do not protrude in a lateral direction from the leadduring advancement of the extraction device. Rather, it is desirous thatthe cables are brought back into substantial contact with the portion ofthe lead over which the lead extraction device is to be advanced. Evenif no known cable separation has taken place, it may still beadvantageous to manage at least the proximal end of the implantedapparatus in the manner described, and as shown in the example of FIGS.3-7. This action would minimize the likelihood of any such separationoccurring during a lead removal procedure, or would bring the cable backinto contact with the lead in the event that an unknown separation hadoccurred.

FIGS. 8-10 illustrate another example of the management of a severedproximal end 202 of a lead 200 utilizing device 10. In this example, acable 210 has worked its way through a length of the outer surface ofthe lead. Other than illustrating a cable protruding therethrough, lead200 is otherwise similar to lead 100 in the example of FIGS. 3-7.Although the example of FIG. 8 illustrates a single cable 210 protrudingfrom a discrete portion of lead 200, those skilled in the art willappreciate that a lead intended for extraction may have more than onecable protruding therefrom, which cable(s) may protrude from differentlengths of the lead.

FIG. 9 illustrates lead 200 after wire 40 has been wrapped around cable210, e.g., in the manner described above with reference to FIGS. 3-7. Asshown, wire 40 brings cable 210 into close contact with the exteriorsurface of the lead. FIG. 10 illustrates the lead and wire of FIG. 9,and also illustrates a lead extraction device 300 positioned foradvancement over lead 200. As stated above, lead extraction devices arewell-known in the art, and the skilled artisan can readily select asuitable extraction device for use in a particular extraction operationwherein wire 40 is wrapped around the lead. By bringing cable 210 inclose proximity to the body of lead 200 prior to advancement ofextraction device 300 over the lead, the extraction device readilyadvances over the entire lead structure, and is not hindered in suchadvancement by the present of a laterally-extending cable or likeelement.

FIG. 11 illustrates a variation of the example of FIGS. 8-10. In thisvariation, wire 40 is also wrapped around locking stylet 120. When acardiac lead has a lumen extending therethrough as described, it may beadvantageous to pass a locking stylet into the lumen in well-knownfashion. In some instances the locking stylet may not fully lock withthe lead when introduced into the lumen, thereby causing the stylet toslip or otherwise disengage when pulled. By wrapping the wire of device10 around the lead and the stylet as shown in the figure, an unintendedwithdrawal or disengagement of the locking stylet from the lead isprevented. Additionally, this arrangement establishes an additionallocking point on the lead, thereby allowing for better overall controlof the lead.

Another variation of device 10 is illustrated in FIGS. 12 and 13. Inthis variation, a tether 80 is engaged with wire 40. FIG. 12 is anexploded view of device 10, as in FIG. 2, wherein tether 80 extends fromwire 40. FIG. 13 illustrates a cardiac lead received along a surface ofthe device, in the same general manner as FIG. 3. A tether may beuseful, e.g., in cases wherein a lumenless lead is being extracted,and/or in cases in which the lead has a lumen extending therethrough andyet it may not be practical to utilize a locking stylet. Tether 80 canbe formed of the same composition as wire 40. The tether will generallyhave a length to enable it to extend through and beyond the extractiondevice.

Those skilled in the art will appreciate that the described features ofdevice 10 need not have the specific configuration shown in theexamples. For example, handle bodies 14, 24 need not necessarily havegenerally flat ledges 15, 25 as shown. Rather, the handle bodies mayhave a gentle curvature, and in some instances may even have a groove,channel, or like structure, as long as the implanted apparatus, such aslead 100, may be controllably received along a surface of the handle.Further, although there may be manufacturing economy in providing twoidentical handles, this is not required, and the respective handles mayhave different configurations. In some instances, only one handle (suchas handle 12 in the figures) need have a ledge or other surface forreceiving the implanted apparatus therealong.

Similarly, handles 12, 22, need not be rounded as shown, as othergeometrically shaped handles will also function in the manner as thehandles shown. Similarly, tabs 16, 26 need not necessarily be integralwith the handle bodies, as non-integral tabs and like structures willnormally be capable of being positioned in like manner to carry out thefunctions of the tabs as described.

Those skilled in the art will also appreciate that device 10 may alsofind other uses in the medical field. For example, if it is desirous toremove a tenaciously-calcified implanted structure, such as an infusioncatheter, from a vessel, a locking stylet-like device or aballoon-tipped removal device may be arranged to engage the distalportion of the structure in well-known manner. In this case, device 10can be arranged to couple the proximal end of the structure to theremoval device. As a result, the physician can extract the implantedstructure by pulling on only one device.

It is intended that the foregoing detailed description be regarded asillustrative rather than limiting, and that it be understood that it isthe following claims, including all equivalents, that are intended todefine the spirit and scope of this invention.

The invention claimed is:
 1. A method for preparing an elongatedimplanted medical apparatus for extraction from the body of a patient,comprising: positioning a device for engagement with a free end of theelongated implanted medical apparatus, the device comprising a firsthandle, a second handle, and a wire member spanning a distance betweenthe handles, the wire member having a first end removably engaged withthe first handle and a second end removably engaged with the secondhandle; aligning the elongated implanted apparatus along a surface ofthe first handle; winding the second handle around a length of theelongated implanted apparatus in a proximal direction from the firsthandle such that the wire is wrapped around said length; and removingsaid first and second handles from said wire wrapped around said lengthof the elongated implanted apparatus.
 2. The method of claim 1, whereinthe surface of the first handle comprises a ledge, and the implantedapparatus is aligned along said ledge of the first handle.
 3. The methodof claim 1, wherein the elongated implanted apparatus comprises acardiac lead having one or more cables extending therein, at least oneof said cables extending laterally through an outer surface of saidcardiac lead, and wherein said winding step comprises wrapping the wirearound said cardiac lead and said laterally extending cable.
 4. Themethod of claim 3, wherein said cardiac lead includes a lumen extendingtherein, further comprising a step of introducing a first end of alocking stylet into said lumen, and wherein said winding step compriseswrapping the wire around the cardiac lead, the laterally extendingcable, and a second end of the locking stylet.
 5. The method of claim 4,further comprising a step of advancing a lead extraction device over thecardiac lead, laterally extending cable, and second end of the lockingstylet having said wire wrapped therearound.